The US FDA Extends Review of sBLA of Ofatumumab (OMB157) for Patients with Relapsing Multiple Sclerosis

 The US FDA Extends Review of sBLA of Ofatumumab (OMB157) for Patients with Relapsing Multiple Sclerosis

The US FDA Extends Review of sBLA of Ofatumumab (OMB157) for Patients with Relapsing Multiple Sclerosis

Shots:

  • Novartis reported that the US FDA has extended its review of sBLA for ofatumumab (OMB 157) to treat patients with RMS. The company anticipates the regulatory action in Sept’2020
  • Novartis works with the US FDA to continue the review for ofatumumab (SC) in RMS, for the approval in the US with expected EU approval in Q2’21. In 2014, Novartis presented P-IIb results demonstrating a reduction in the number of new brain lesions in the first 24 wks. while the Novartis has initiated P-III program for ofatumumab in RMS in August 2016  
  • Ofatumumab (SC, once monthly) is a CD20 mAb, targeting CD20 molecule on the B-cell surface and inducing potent B-cell lysis and depletion. The therapy was originated by Genmab and licensed to GSK, later, Novartis gets rights for ofatumumab from GSK in all indications, including RMS, in Dec’2015

Click here to read full press release/ article | Ref: PRNewswire | Image: Twitter

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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